(240 days)
The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
- · 250°F/121°C, 30 minutes Gravity
- · 270°F/132°C, 4 minutes Dynamic Air Removal
- · 270°F/132°C, 15 minutes Gravity
- · 275°F/135°C, 3 minutes Dynamic Air Removal
- · 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
- · 270°F/132°C, 4 minutes Dynamic Air Removal
- · 270°F/132°C, 3 minutes Gravity
- · 270°F/132°C, 10 minutes Gravity
- · 275°F/135°C, 3 minutes Dynamic Air Removal
- · 275°F/135°C, 3 minutes Gravity
- · 275°F/135°C, 10 minutes Gravity
The VERIFY® STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer manufacturer's directions. Prior to the use of the processed items, the Integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.
The provided document details the acceptance criteria and the study that proves the VERIFY® STEAM Integrating Indicator device meets these criteria.
Here's the extracted information:
- Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Study Result |
|---|---|---|
| BIER Vessel Testing | Pass result at Stated Value (SV) for each temperature claimed (23.0 min at 121°C, 2.0 min at 132 °C, 1.2 min at 135 °C) AND Fail result at 15% below SV for each temperature claimed AND Fail result at 1°C below SV for each temperature claimed | PASS |
| Simulated Use Testing in Claimed Sterilization Cycles | 100% Pass result under pass conditions AND 100% Fail result under fail conditions | PASS |
| Dry Heat Testing | Fail result when exposed to 140°C dry heat for 30 min | PASS |
| Verification of integrator stated values at biological indicator growth-negative cycle conditions | Integrator does not reach endpoint before the biological indicator is inactivated | PASS |
| Offset/Bleeding | Integrator shall not bleed or offset | PASS |
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Sample size used for the test set and the data provenance
- Sample Size: The document states that testing was performed on "3 Lots" for the BIER Vessel Testing. Specific numbers of individual devices tested within each lot are not provided.
- Data Provenance: The study was conducted by STERIS Corporation for FDA submission. Details on the specific country of origin for the testing data are not explicitly stated, but the company is based in Mentor, Ohio, USA, and the documentation pertains to submissions to the U.S. FDA. The study appears to be prospective testing specifically for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a chemical indicator for sterilization. The "ground truth" is established by the physical and chemical parameters of the sterilization cycles (time, temperature, steam presence) and the inactivation of biological indicators. It does not involve human expert interpretation in the way, for example, a diagnostic imaging device would.
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Adjudication method for the test set
- This is not applicable for a chemical indicator. The endpoint is a visual change (migration of a dark bar into an "ACCEPT (OK)" window) determined by the chemical reaction to physical parameters, not human interpretation requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable to this device. The VERIFY® STEAM Integrating Indicator is a standalone chemical indicator, not an AI-powered diagnostic tool requiring human interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, essentially. The performance testing described (BIER Vessel Testing, Simulated Use Testing, Dry Heat Testing, BI growth-negative cycle, Offset/Bleeding) evaluates the device's inherent physical and chemical behavior in response to sterilization conditions, independent of active human intervention during its function. Its output (pass/fail indication) is then read by a human.
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The type of ground truth used
- The ground truth is based on the physical parameters of the steam sterilization cycles (time and temperature) and the inactivation of biological indicators (BIs). The device's chemical reaction indicates whether these critical parameters have been met sufficiently to achieve sterilization, which is then correlated with BI inactivation.
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The sample size for the training set
- This information is not explicitly provided. Chemical indicators are typically characterized and validated, but the concept of a "training set" as understood in machine learning/AI is not directly applicable here. The device's performance is based on its physical design and chemical formulation, which would have been developed and refined through R&D (implicitly "trained" on various conditions) rather than a formal machine learning training set. The approval document focuses on validation/verification testing.
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How the ground truth for the training set was established
- As noted above, the concept of a "training set" in the context of AI is not applicable. The device's "ground truth" for its development would have been established through extensive laboratory characterization of its chemical reaction kinetics under varying steam sterilization conditions (temperature, time, steam presence) to ensure it correlates accurately with microbial inactivation (sterilization). This would involve controlled experiments in BIER vessels and other sterilization equipment across a range of conditions, using established sterilization principles and biological indicators as the ultimate arbiters of sterilization effectiveness.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).